FDA issues EUA for intradermal injections of JYNNEOS monkeypox vaccine

As the monkeypox virus continues to spread and health officials warn that vaccine supply is not meeting demand, the United States Food and Drug Administration (FDA) this week granted an emergency use authorization (EUA) to intradermal injections of Bavarian Nordic’s JYNNEOS vaccine.

The vaccine has been the sole vaccination for the disease relied upon by the U.S. government, though the speed of acquisition and deployment has at times been held up –- most notably by necessary overseas inspections. With this authorization, though, regulators noted that the total number of available doses for those 18 years old and older — and at high risk of monkeypox infection — will increase five-fold. Further, it actually expanded use of subcutaneous injection to those younger than 18 as well.

Younger users are still forbidden intradermal injection, however.

“In recent weeks the monkeypox virus has continued to spread at a rate that has made it clear our current vaccine supply will not meet the current demand,” FDA Commissioner Robert Califf, M.D., said. “The FDA quickly explored other scientifically appropriate options to facilitate access to the vaccine for all impacted individuals. By increasing the number of available doses, more individuals who want to be vaccinated against monkeypox will now have the opportunity to do so.”

JYNNEOS was approved for use in preventing smallpox and monkeypox in 2019 among adults at high risk. Formerly, its main use was subcutaneously, meaning administered beneath the skin, through two doses spread four weeks apart. Intradermal injections are administered between layers of the skin, though the dose requirements are no different. Neither iteration has been in use long enough to gather data on JYNNEOS’ long-term protection capabilities, if any.

Monkeypox was declared a public health emergency in the U.S. earlier this month, after the World Health Organization (WHO) declared it a Public Health Emergency of International Concern in July. According to data from Aug. 9, 2022, the Centers for Disease Control and Prevention (CDC) had confirmed nearly 9,500 cases in the U.S. alone.

This week’s action on JYNNEOS followed invocation of Section 564 of the Federal Food, Drug and Cosmetic Act, through which the Department of Health and Human Services (DHHS) cleared use of EUAs on monkeypox vaccines owing to the ongoing emergency. The department further emphasized that, to date, more than 1.1 million doses of the JYNNEOS vaccine have been made available and more than 620,000 doses shipped nationwide. Commercial lab partnerships are also increasing testing capacity as time goes on.